CIVCO Medical Solutions is seeking a motivated and detail-oriented Tooling Engineer I to contribute to the design, development, and maintenance of tooling, equipment and fixtures used in the manufacturing of injection-molded and machined medical devices. This position offers an exciting opportunity to learn and grow within a dynamic engineering team, directly impacting the production and quality of life-changing medical products. The Tooling Engineer I will work closely with manufacturing engineers, quality assurance, and production teams to ensure efficient and reliable manufacturing processes.

Responsibilities:

• Assist in the design, development, and validation of new tooling, fixtures, and gauges for various manufacturing processes, including machining, molding, assembly, and packaging.
• Create and maintain detailed tooling drawings, specifications, and documentation using CAD software (e.g. Creo).
• Collaborate with external vendors and suppliers in the fabrication and procurement of tooling components.
• Participate in the troubleshooting and resolution of tooling-related issues on the production floor to minimize downtime and ensure product quality.
• Support the implementation of tooling improvements and modifications to enhance efficiency, reduce costs, and improve safety.
• Assist in the development and execution of tooling validation protocols (IQ, OQ, PQ).
• Maintain accurate records of tooling inventory, maintenance schedules, and repair activities.
• Adhere to all company policies, procedures, and regulatory requirements, including those related to quality systems (e.g., ISO 13485, FDA regulations).
• Participate in cross-functional teams to support new product introductions and process improvements.
• Continuously seek opportunities to expand technical knowledge and skills related to tooling and manufacturing technologies.
• Perform other related duties as assigned.

Qualifications:

• Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or a relevant discipline.
• 0-2 years of experience in a manufacturing environment, preferably within the medical device or a similarly regulated industry.
• Basic understanding of tooling design principles, materials, and manufacturing processes (e.g., machining, injection molding, inspection).
• Proficiency in CAD software (e.g., Creo) for creating and modifying drawings.
• Familiarity with GD& T (Geometric Dimensioning and Tolerancing) principles.
• Strong problem-solving and analytical skills with the ability to troubleshoot technical issues.
• Excellent communication, interpersonal, and teamwork skills.
• Ability to work independently and manage multiple tasks effectively.
• A strong commitment to quality and attention to detail.
• Knowledge of medical device regulations (e.g., FDA 21 CFR Part 820, ISO 13485) is a plus.
• Experience with metrology and measurement equipment is a plus.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit; reach with hands and arms and talk or hear. The employee is frequently required to use hands to finger, handle, or feel. The employee is occasionally required to stand; walk; climb or balance and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, color vision, depth perception and ability to adjust focus.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is frequently exposed to moving mechanical parts. The employee is occasionally exposed to toxic or caustic chemicals and risk of electrical shock. The noise level in the work environment is usually moderate.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
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